Recital 35

(35) Modification of a product, by physical or digital means, might have consequences on the nature and characteristics of the product in a way which was not foreseen in the initial risk assessment of the product and which might jeopardise the safety of the product. Such modification should therefore be considered as a substantial modification and, when not done by the consumer or on his behalf, should lead to the product being considered as a new product from a different manufacturer. In order to ensure compliance with the general safety requirement laid down in this Regulation, the person that carries out that substantial modification should be considered as the manufacturer and subject to the same obligations. That requirement should only apply with respect to the modified part of the product, provided that the modification does not affect the product as a whole. In order to avoid an unnecessary and disproportionate burden, the person carrying out the substantial modification should not be required to repeat tests and produce new documentation in relation to aspects of the product that are not impacted by the modification. It should be up to the person that carries out the substantial modification to demonstrate that the modification does not have an impact on the product as a whole.

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Source: EUR-Lex CELLAR · retrieved 2026-08-26 · Text as adopted (Official Journal); later amendments are not incorporated in this text.